Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
- Breaking Down The CDMO Size Barrier
- New ICH Q14 Guidance Applies QbD To Analytical Procedures
- Key Considerations In Early-Stage Biopharma Financing
- Here’s How To Grow With Your CDMO
- Make This Your New EU IDMP Implementation Strategy
- Gene Therapy Competitive Dynamics: Winner Takes All?
- Key Considerations For Decarbonizing Your Biotech Facility
New ICH Q14 Guidance Applies QbD To Analytical Procedures
ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.
Key Considerations In Early-Stage Biopharma Financing
After over two years of soaring IPO valuations and high stock prices, biotech had a reckoning in the back half of 2021. But while the industry is clearly facing headwinds, there’s significant cause for optimism for early-stage biotechs looking for funding, not the least of which is 2021’s high levels of venture capital fund formation.
Make This Your New EU IDMP Implementation Strategy
Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.
Gene Therapy Competitive Dynamics: Winner Takes All?
A one-time gene therapy treatment with the potential to cure patients could create a “winner takes all” dynamic, whereby second and later entrants for the same indication would have significantly smaller patient populations. The extent to this dynamic will occur will depend on how similar gene therapy treatments are considered by payers, KOLs, and physicians to be comparable.
Key Considerations For Decarbonizing Your Biotech Facility
Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.
How Will Advanced Computing Technologies Catapult Medtech Into The Future?
There is an almost unlimited profit potential for medtech manufacturers to use advanced computing technologies such as AI, faster and smaller computing hardware, computing-driven robotics, AR/VR, and IoT to build devices that disrupt markets and improve people’s lives. This article delves into using data analytics (including AI), making more effective implantable devices, and collecting better patient data.
Don’t Neglect This Drug Development Milestone: The Pre-IND Meeting
The pre-IND meeting takes place when a sponsor presents their planned Phase 1 study design, including their proposed product development plan and regulatory strategy, to the FDA. Think of this as a necessary milestone for a quicker development timeline. This article shares best practices for preparing for the meeting as well as for the meeting itself.
How To Evaluate & Manage Safety Risks In Biopharma
Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).
PHARMA OUTSOURCING WHITE PAPERS
Rational Design Of Oral Nanosuspensions For Insoluble Drugs
The advantages of nanosuspension dosage forms include improving bioavailability and API stability, increasing drug loading, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.
Age-Appropriate Pediatric Formulation Development
There is a significant variability in the pharmacokinetics of the same drug and dosage form between pediatric and adult populations, and the factors impacting drug bioavailability are different in children.
CDMO Collaboration: Foundation For Sterile Injectable Product Success
Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.
End Of End Point Assays: SPR Analytics In Vaccine Design, Development
Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.
Navigating The Adoption Of Continuous Pharma Manufacturing
Driving a path forward for continuous manufacturing calls for a closer look at current global challenges, any existing barriers, and the ideas and initiatives necessary to fulfill its potential.
Nanosuspension Dosage Forms: Product Development & Scale Up
For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.